Funding

Clinical Research

Updated September 10, 2007

This sample patient consent form for a drug study serves as an example to guide investigators who intend to conduct research with human subjects. The intent of the document is not to suggest required wording or format, but rather to provide categories and level of detail that are pertinent to many clinical trials. Investigators should refer to their institutional requirements for guidance on specific required sections, such as financial conflicts of interest or descriptions of study oversight.

Clinical Investigation Consent Form

We invite you to take part in a research study (title) at (location/institution), which seeks to identify a more effective means of treating (illness, condition). Taking part in this study is entirely voluntary. We urge you discuss any questions about this study with our staff members.

Purpose Of The Trial

This research is being done because we do not know the best treatment for this kind of disease. (Give description of disease/condition; what it is, its cause, the symptoms, medicines/techniques frequently used to treat it, etc.)

(Explanation of Research Project and intervention to Subject)

The purposes of this study are to:

  • Find out what effects (good and bad) the drug has on you and your disease
  • Measure the amount of drug in the blood to see how long it stays in your body

Investigators: (names)

How Many People Will Take Part In The Study?

About 40 people will take part in this study.

Procedures

If you agree to participate, the following tests and procedures will be performed during the study (example):

  • A medical history and physical examination
  • Blood tests to assess the degree of disease activity as well as the functional status of your liver, kidneys, and other organs (this will require about n teaspoons of blood)
  • A urine test
  • A chest X-ray
  • If you are a woman of child-bearing potential, a pregnancy test will be done.
  • You will fill out a questionnaire about the impact of your disease on your quality of life (this will take approximately n minutes)
  • HIV testing

Some of these tests would be done even if you do not take part in the study.

Sample Storage and Use
The blood and urine tests will be repeated at regular intervals throughout the study. Some of the blood and urine tests will be used for studies related to the cause, prognosis, and disease mechanisms of the disease. Some of your blood will be stored for purposes of future research studies specifically related to the disease. These studies may involve testing for the presence of genes (DNA) and investigations of blood factors (e.g., antibodies or novel inflammatory proteins) that may influence the risk of getting the disease, the risk of having a severe form of the disease, and the chance of responding to treatment.

Treatment Assignment
If you agree to participate, you will be assigned by "chance" (like flipping a coin) to either: 1) experimental treatment or 2) a placebo. A placebo is a liquid that looks like the drug liquid but has no drug in it. Both the drug and the placebo are given by injection with a small needle under the skin, twice a week. You will not know which treatment you are taking. Your physician will also not know whether you are taking the drug or placebo. The code that tells which patients are receiving the drug and which are receiving placebo will be kept by the study coordinating center. This code will be kept private until the end of the study, unless it is necessary to break the code in the interest of your safety. Depending on your symptoms and the lab results, the doses of some of the medications used in the study (all except for the drug or the placebo, which will remain the same unless they need to be stopped entirely) may be changed by your physician. Once you have clearly responded to treatment, which is expected to occur within several weeks in both groups, some of your medicines will be tapered over a period of months.

Treatment Visits
Following your entry visit, you will have a study visit at one six week interval, and then every 3 months from time of entry (entry, 6 weeks, 3 months, 6 months, 9 months, 12 months, etc.) until the end of the trial. Each appointment will take approximately 1-2 hours. This appointment schedule is typical for a patient with (disease) whether or not the patient is enrolled in a study. If your medical condition requires additional evaluations, other visits will be scheduled as necessary. During all of these visits you will be examined by a physician, and about 8 teaspoons of blood will be taken from a vein in your arm. This would be commonly done even if you were not in a research study. You will also give urine specimens at each visit.

Risks / Discomforts

While on the study, you are at risk for the following side effects. Most of them are listed below but they will vary from person to person. Drugs will be given to make some of the side effects less serious and uncomfortable. Many side effects go away after the drug is stopped but, in some cases, the side effects may be serious and/or lasting.

Risks Associated With Standard Medicines Used To Treat (disease name)
Prolonged use of [drug name(s)] may be associated with significant side effects, including: (list). All of these can be serious complications.

Because the standard therapies used to treat the disease have significant potential side effects, you will be asked to take medications to prevent the occurrence of as many of these side effects as possible. These preventive medicines include: (list medicines and what they do).

If you are taking (drug name) as part of your treatment for the disease, we strongly discourage the drinking of alcohol. In order to participate in this trial, you must be willing to limit your intake of alcohol to 1 alcoholic drink or less per week.

Risks Associated With The Use Of (Drug name)
In studies comparing the drug to placebo, side effects that occurred more frequently in the drug-treated patients were mild reactions at the site of injection under the skin. Injection site reactions consisted of redness, pain, swelling, or itching. In a small percentage of patients treated with placebo, injection site reactions have also occurred, consisting of redness, pain, swelling, or itching. Allergic reactions have also been reported rarely in patients treated with the drug.

(Describe what the drug is and what it does.)

It is still possible that the drug may make infections worse and could result in life-threatening complications. If you develop signs and symptoms of a significant infection, you should contact your physician immediately to determine whether you should interrupt drug dosing.

A small number of people receiving the drug have formed antibodies against the drug although these antibodies do not appear to be active in blocking the effect of the drug. Any further consequences of an individual having antibodies to the drug are not known.

All men and all women of childbearing potential must practice an adequate method of birth control while participating in this trial and for n months after stopping the experimental treatment. Adequate methods of birth control include: sexual abstinence (not having sex), oral contraceptives ("birth control pills") or other hormone-based method, the combined use of condom and diaphragm, the combined use of diaphragm and spermicide, tubal ligation, and vasectomy. Inadequate methods include: the rhythm method, withdrawal, condoms (alone), diaphragm (alone), and an intra-uterine device (IUD).

Pregnant or nursing women, women of childbearing potential, and fertile men not using an adequate method of birth control are not permitted to participate in this study because the risks of the study drug to an unconceived, unborn, or newborn child are not known. If you are a woman who could become pregnant, you will agree to notify your physician immediately if you suspect or know you are pregnant while on the study. If you are still receiving study drug, you will discontinue the experimental medication, but will continue to be followed as a patient in the trial. In other words, you will be withdrawn from the study, but will be asked to return for the rest of the evaluations for the purpose of gathering safety and drug effectiveness information.

There may be other as yet unidentified side effects that could occur during the time you participate in the study or years after receiving the drug. If there are any significant new findings that may affect your willingness to continue in the study, you will be notified.

In order to minimize or avoid the risks and hazards associated with the use of the drug, the following will be performed:

  1. Study medications will be given under close supervision of your study doctor, who will perform frequent evaluations.
  2. In order to safeguard against blood, liver, kidney or other organ damage possibly caused by any of the study medications, blood and urine tests will be performed regularly.
  3. If dangerous or otherwise intolerable side-effects occur, the study medication will be stopped.
  4. You should report any unusual reactions promptly to your study doctor.

Other Possible Risks Associated With Participating In This Study
Venipuncture: The risks of drawing blood include temporary discomfort from the needle stick, bruising, bleeding, and rarely, infection.

HIV Testing: The HIV test requires the drawing of blood. Being tested for HIV may cause anxiety regardless of the test results. A positive test means that you have been infected with the HIV virus, but nobody can say for certain when, if ever, you will become sick with AIDS or a related condition. Receiving positive results may make you very upset. If other people learn about your positive test results, you may have trouble obtaining insurance or employment. If your test is negative, there is still the possibility that you could be infected with the HIV virus and test positive at some time in the future. There is always the possibility that the test results could be wrong.

Subcutaneous Injections: Injections to the skin may be less convenient than some other forms of treatment, such as oral medications. In addition, injections may cause momentary discomfort and other local symptoms, such as bleeding, bruising, and, rarely, infection.

Radiation: The amount of radiation that you will be exposed to is relatively small. The radiation exposure you will receive from a conventional chest x-ray is equivalent to an exposure of 0.007 rem to your whole body. Naturally occurring radiation (cosmic radiation, radon, etc.) produces whole body radiation exposures of about 0.3 rem per year. Occupationally exposed individuals are permitted to receive whole body exposures of 5 rems per year. Such doses are usually not harmful, but if you have already had many x-rays, you should discuss this with the study doctor.

Benefits

The possible benefits to you include the following: increased chance of achieving a remission of the disease; diminished chance of the return of the disease; diminished use of standard treatment medications and thus a decreased risk of side effects caused by these medications. It cannot be guaranteed that you will receive any benefits from this study. Benefits to others may include knowing the safety and effectiveness of the drug in the treatment of the disease. There is no guarantee that the study medication will be provided beyond the n to n month study period.

Alternatives To Participation In This Study

If you are not eligible or decline to participate in this study, you will receive standard treatment for the condition. Your signature below indicates that the doctor identified at the end of this form or one of his or her associates has discussed with you alternative ways your condition might be treated should you decide not to participate in this particular study.

Right To Refuse Or Withdraw
The choice to enter or not enter this study is yours. You are in a position to decide if you understand both what the doctor has explained and what you have read about the study. If you decide not to participate, other choices are available to you without prejudice. If you begin the study, you have the right to withdraw at any time. If you withdraw, you will be offered other care according to your condition. In either case, there will be no penalty or loss of benefits to which you are entitled.

Reasons For Withdrawal From The Study Without Your Consent
If any of the following things happen, you will be withdrawn from the study without your consent:

a) The investigator decides that continuing in the study would be harmful to you;
b) You need a medication not allowed on this study;
c) You fail to keep appointments or take medications as instructed;
d) You have a serious adverse reaction to the study medications/treatments;
e) You become pregnant;
f) The study is cancelled by the National Institutes of Health or the Food and Drug Administration.
g) Discovery of alcohol abuse if you are taking a drug as part of your treatment for the your condition.

Costs Or Payments

There is no cost to you for the drug or the placebo medications, or for laboratory tests or examinations that are not standard in the treatment of the disease. The medical costs of clinic visits and examinations and laboratory tests that are standard in the treatment of the disease will be charged to you and your health insurance company. You will be reimbursed $n for each regularly-scheduled trial visit for costs incurred in participating in this study.

Confidentiality

We are collecting data for the purpose of this study. We will keep the data at your clinic and at the study coordinating center in (location). Your research records will be kept confidential to the extent permitted by the law. You will be identified by a study number and personal information from your records will not be released without your written permission.

Unless required by law, only the team of investigators involved in this study, the Institutional Review Boards of universities participating in the study, the National Institutes of Health or its representatives, the Data and Safety Monitoring Board, the United States Food and Drug Administration, and the pharmaceutical company providing the medication will have access to your study data sets that do not include personal identifiers. All of these people are also required to keep your identity confidential. Otherwise, the information that identifies you will not be given out to people who are not working on the study, unless you give permission. Medical information from the study will be made available to your physician unless you specify otherwise. If a health condition is detected during the study, you will be told about it and the information will be given to your doctor or clinic.

A Safety Officer has been named to monitor the safety of this clinical trial. He or she will review data routinely to assess safety concerns. Your records from this study will be retained for seven years. Your identity will not be revealed in any publication or release of results. This study is authorized by Privacy Act 42 United States Code 241.

If you have any questions about any part of the study or your rights as a volunteer, a staff member will be on hand to answer them before you sign this consent form. If you have any questions at any time you may call Dr. XX at (phone #), or any of the staff members listed at the beginning of this document.

Questions You May Have About The Research Study

This consent form explains the research study. Please read it carefully. Ask questions about anything you do not understand. If you do not have questions now, you may ask later. During the study, you will be told any new facts that could affect whether you want to stay in the study. If the study relates to a health problem you have, we will explain what other treatment could be given outside the research. You should understand those options before you sign this form. If you have questions you should contact the principal investigator name at phone , email .

If You Are Hurt By Being In The Study

If you think you have been hurt by being in the study, or not treated fairly, you should call (specify individual) to receive help or advice, including help finding medical care if needed. The (institution name) and the Federal government do not have any program to pay you if you are hurt or have other bad effects which are not the fault of the study doctors. If you are injured as a result of being in this study, treatment will be available.

Joining Of Your Own Free Will (Volunteering for the study)

You do not have to join this or any research study. If you do join, and later change your mind, you may quit at any time. All normal treatment options will still be available to you.

What Your Signature Means

Before you sign this form, please ask questions about any part of this study that is unclear to you. Your signature below means that you understand the information given to you about the study and in this consent form. If you sign the form it means that you agree to join the study.

We Will Give You A Copy Of This Consent Form.


____________________________________________
Subject's signature
(including children, when applicable)

Date


____________________________________________
Signature of Parent or Guardian (when applicable)

Date


____________________________________________
Signature of Investigator or Approved Designee

Date


____________________________________________

Witness to Consent Procedures *

Date

*Optional unless subject is illiterate, or unable to sign

NOT VALID WITHOUT THE COMMITTEE OR IRB STAMP OF CERTIFICATION





VOID ONE YEAR FROM ABOVE DATE RPN NO: __________


NOTE: A COPY OF THE SIGNED CONSENT FORM MUST BE KEPT BY THE PRINCIPAL INVESTIGATOR AND A COPY OF THE CONSENT FORM MUST BE PLACED IN THE PATIENT'S MEDICAL RECORD.